Support device or system for positioning infant or patient for lumbar puncture or other medical procedures and use thereof

Abstract

The invention relates to a supporting system or device for lumbar puncture. Specifically, the present invention includes a lumbar puncture support system / device for positioning an infant that maintains the infant in an optimal fixation condition during a lumbar puncture. The apparatus includes a seat defining a leg support portion, a hip support portion, and a back support portion. The buttocks support portion and the back support portion receive the buttocks of the infant. The position of the leg supporting part is higher than that of the hip supporting part, so that the thighs and knees of the infant are close to or in contact with the upper body of the infant, and therefore the clear and exposed back of the infant is provided for lumbar puncture.

Description

Cross Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 516,191, filed July 28, 2023, the entirety of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present invention relates to a support system or device for lumbar puncture, particularly for pediatric patients or infants. BACKGROUND

[0003] During routine medical care of infants, a procedure known as “lumbar puncture” can be required, which involves inserting a needle into the bottom of the spine (between two bones of the lower back (L1 to L5) in order to withdraw fluid for diagnostic purposes. The target area for obtaining this fluid is approximately 3 to 5 mm in diameter.

[0004] Successfully performing a lumbar puncture is a challenge for both the patient / infant and the medical staff. Currently, the failure rate for lumbar puncture (in infants) is as high as 50%.

[0005] Numerous factors, including the following, can contribute to the success or failure of the procedure: 1) the clinical condition of the infant; 2) the management of pain associated with the range of motion of the patient; 3) the experience, skill and confidence of the operator performing the procedure; and 4) the experience of the assistant positioning the infant’s posture.

[0006] In a traditional lumbar puncture, the infant / patient is positioned in a lateral decubitus position, as shown in Figure 1 or in a sitting position, as shown in Figure 2 and Figure 3 .

[0007] The lateral decubitus position is the most conventional approach, as the patient appears to be more stable; however, the alignment of the spine is often disrupted / inconsistent / less than ideal and poses other challenges to the success of the procedure. On the other hand, the sitting position, while associated with better outcomes, is often avoided due to the complexity of the technique required to maintain the posture. The traditional body positions or approaches do not properly position the infant in the best way possible and are unable to maintain a high quality of immobilization of the infant during the lumbar puncture.

[0008] Various attempts have been made to address one or more of the above issues. For example, Chinese Patent No. CN110559149B and Chinese Utility Model Patent Nos. CN212997262(U) and CN218338668(U) provide devices that keep a patient in a lateral decubitus position, each document detailing a bed and / or device in which a patient is laid on their side with their knees close to their chest / upper body to arch the baby’s back and expose it for surgery, and various methods to safely secure the patient’s body. While these measures attempt to provide a more stable means for surgery, they fail to fundamentally address the issue of frequent misalignment / tangling of the spine as described above.

[0009] Various other attempts have also been made to position a patient in a sitting position for a lumbar puncture. For example, French Patent Application Publication No. FR3095121 shows a chair for a lumbar puncture in which a patient would sit on the chair, hugging the front support of the chair to expose the back for surgery. U.S. Patent Application Publication Nos. US20070272254A1 and US20230200560A1 disclose a device for positioning a patient for a lumbar puncture in which the patient needs to face and embrace the device so that the patient’s back arches and is exposed for surgery. While these solutions can be adjusted or modified for use with babies; their structure does not allow the natural curling of the spine, thus failing to provide a clearer, more effective exposure for a lumbar puncture.

[0010] Accordingly, there is an increasing need for a system, i.e. a tool or device, to address these shortcomings and improve the success rate of lumbar punctures in babies. SUMMARY

[0011] According to one object of the present invention, the present invention provides a system, device, and tool that improves the positioning of a baby during a lumbar puncture while maintaining a higher quality of fixation.

[0012] According to another object of the present invention, the present invention provides a baby / child sitting device that provides a better positioning solution for the doctor / operator, thus improving the stability, comfort, and safety of the baby during a lumbar puncture and improving the success rate.

[0013] According to one preferred embodiment of the present invention, the present invention provides a device for positioning a baby for a lumbar puncture, comprising: a seat that defines a leg support portion, a hip support portion, and a back support portion, wherein the hip support portion and the back support portion accommodate the baby’s hips, and the leg support portion is positioned higher than the hip support portion to bring the baby’s thighs and knees close to or in contact with the baby’s upper body, thus exposing the baby’s back for a lumbar puncture. BRIEF DESCRIPTION OF DRAWINGS

[0014] The invention will now be described in more detail with reference to the accompanying drawings, in which: Figures 1 to 3 The standard position for an infant during a lumbar puncture is shown. Figure 4 This is a perspective view of a first embodiment of the support system for lumbar puncture according to the present invention; Figure 5 This is its rear view; Figure 6 This is a magnified view of a portion of it; Figure 7 Another rear view of an infant being placed on the system; Figure 8 This is its side view; Figure 9 This is a view of an infant placed on the system from the other side. Figure 10 This is a perspective view of a second embodiment of the support system for lumbar puncture according to the present invention; Figure 11 This is its rear view; Figure 12 It is its side view in three dimensions; Figure 13a This is its side view; Figure 13b This is a front view of the chair seat; Figure 13c It is along Figure 13b Right side view of the cross-section of the chair seat along the DD line; Figure 14 This is another three-dimensional image of it; Figure 15 This is its rear-view stereoscopic view. Detailed Implementation

[0015] Figures 4 to 9 A first embodiment of a support system 100 for lumbar puncture according to the present invention is shown.

[0016] The support system 100 includes a seat 10 for placing the infant 5. For example... Figure 9 As shown in the side view, the seat 10 contacts the lower body of the infant 5, thus defining the leg support portion 10a, the hip support portion 10b, and the back support portion 10c. The leg support portion 10a and the hip support portion 10b are arranged / positioned such that the infant 5's thighs are higher than the infant 5's hips, so that the infant 5's thighs / knees are closer to or in contact with the infant 5's chest / upper body. The hip support portion 10b and the back support portion 10c define a recess / slot 10d for receiving / fixing the infant 5's hips, allowing the infant's back to be slightly curved and clearly and stably exposed for lumbar puncture.

[0017] To help the infant 5 maintain a flexed posture, the support system 100 also includes a body immobilizer 18 for securing the infant 5 in a flexed body position / posture. The body immobilizer 18 includes a vertical bar 12 and a contact horizontal bar 11. The vertical bar 12 is pivotally connected to the seat 10 via a pivot member (or crossbar) 13 located at one end of the vertical bar 12, and the contact horizontal bar 11 is located at the other distal end of the vertical bar 12. Figure 9 As shown, the contact bar 11 contacts the upper abdomen / lower chest of the infant 5 and presses the thigh above the knees down against the seat 10 to facilitate a flexed position / posture to expose the lower back of the infant 5. The height of the contact bar 11 can be adjusted along the vertical bar 12. The vertical bar 12 is telescopically extendable, and its height (or length) can be releasably adjusted using a height adjustment device 14. For example, the height adjustment device 14 includes a first bar 14a and a second bar 14b that telescopically / slidably engage with each other. The first bar 14a defines a plurality of predetermined positions or through-holes 14c, and the second bar 14b includes a releasable latch that engages with a desired position 14c to provide the desired height position. Various other methods / means can be provided to achieve substantially the same or similar functionality.

[0018] In order to effectively control the movement of the baby's legs, the support system 100 also includes leg dividers 10e for opening the legs and restricting the movement of each leg separately.

[0019] refer to Figure 6 To further facilitate the flexed posture of the infant 5, the support system 100 provides a lateral body immobilizer 19 on the sidewall 17. The lateral body immobilizer 19 is adjustable to accommodate infants of different sizes. For example, according to one embodiment of the invention, the lateral body immobilizer 19 includes an actuator 16, which comprises a screw member 16b having a handle 16c. A washer (rotating pad or movable claw) 16a is provided at the other end of the screw member 16b, which engages / contacts the side of the infant 5's buttocks. Ports / holes 15 are provided on the sidewall 17 of the seat 10, each port 15 for receiving the actuator 16. The user uses the handle 16c to drive the screw member 16b to adjust the distance from the sidewall 17 to properly engage the rotating pad 16a, thereby engaging the anterior superior iliac spine of the infant 5's buttocks, thus immobilizing the infant 5's lower body / pelvis to minimize movement / keep it stationary. Figure 9 As shown, the infant 5 is tilted forward and above the horizontal bar 11, so that the infant's back is easily exposed for lumbar puncture.

[0020] The support system 100 can be made of a suitable material such as plastic or acrylonitrile butadiene styrene (ABS) and can further be configured with a comfort pad made of a safe soft material such as ethylene vinyl acetate copolymer (EVA).

[0021] Figures 10 to 1 6 shows a support system 200 for lumbar puncture according to a second embodiment of the present application. The support system 200 comprises a chair seat 27. The chair seat 27 can be made of a suitable material such as plastic or acrylonitrile butadiene styrene (ABS). For contact with the lower body of the baby 5, the chair seat 27 is provided with a seat foam 26. The seat foam 26 can be made of a suitable material such as ethylene vinyl acetate copolymer (or EVA) foam.

[0022] Referring to Figure 13b and Figure 13c like the support system 100, the chair seat 27 and the seat foam 26 are shaped such that portions 27b and 27c of the seat foam 27 / chair seat 27 are in contact with the hips of the baby 5, forming a dip / indentation 27d to facilitate the bending of the body at the hips. When the baby 5 is seated, the hips of the baby 5 are positioned lower than the back of the thighs, while the back of the thighs are positioned on the leg support portions 27a of the seat foam 26 / chair seat 27. This shape of the chair seat 27 and the seat foam 26 brings the upper thighs / knees of the baby 5 close to the chest / upper body, so as to better expose the lower back of the baby 5 for lumbar puncture.

[0023] To facilitate the baby 5 to maintain a stable bent position, the support system 200 further comprises a body holder 30 for holding the bent body position of the baby 5. The body holder 30 comprises a chest rest 24. The chest rest 24 comprises a shoulder portion 24b shaped to embrace and press down on the shoulders of the baby 5 to prevent or minimize upward movement of the upper body of the baby 5 during the procedure. The chest rest 24 also defines a chin rest portion 24a, as Figure 12 shown, for receiving the chin of the baby 5. The chair seat 27 comprises a mirror handle 28 extending upwardly from the front of the chair seat 27 for receiving the chest rest 24. The chest rest 24 is designed to be slightly tilted forwardly so that the chest of the baby 5 will naturally rest on the chest rest 24 with the chin of the baby 5 resting on the chin rest portion 24a of the chest rest 24 and the shoulder portion 24b of the chest rest 24 holding the shoulders of the baby 5 downwardly or towards the chair seat 27. To make the baby 4 more comfortable, foam 21 is used on the contact surfaces of the chest rest 24.

[0024] The foam 21 can be made of a suitable material such as ethylene vinyl acetate copolymer (or EVA) or similar safe soft material.

[0025] To effectively control the movement of the baby's legs, the mirror handle 28 also acts as a leg divider to open the legs while sitting and to restrict the movement of each leg separately.

[0026] The mirror handle 28 and the chest support 24 are inclined forward to incline the baby 5 forward and rest the upper body on it, thereby providing stable support to maintain the curved posture as Figure 12 shown. The angle of the mirror handle 28 and the chest support 24 can depend on the depth and shape of the recesses / nests 27d on the seat foam 26 and the chair seat 27.

[0027] The lock 23 is provided with a release handle / locking handle 25. The chest support 24 is telescopically and slidably engaged with the mirror handle 28. The locking handle 25 is releasably engaged to lock the chest support 24 at the desired height. As Figure 13a shown, the locking handle 25 can act as a height adjustment lever for driving the means to adjust the height of the chest support 24.

[0028] To better achieve the pelvic / hip fixation, the support system 200 further comprises lateral body fixators 31, such that the chair seat 27 can be adjusted according to the size of the baby to fix the position of the lower body, including the general positioning of the lumbar spine in frontal (coronal) and longitudinal (sagittal) movements.

[0029] For example, with reference to Figure 10 and Figure 14 , the lateral body fixators 31 comprise actuators (not shown) driven by handles for the seat adjuster 22, which are provided on the sides of the chair seat 27. A pawl / pad (not shown in the figures) is provided below the seat foam 26 to engage / contact one side of the hips of the baby 5 to fix the hips of the baby 5. The handles 22 can be operable, i.e. moved upward or downward to drive the pawl / pad to adjust the degree of compression of the side walls 29 of the seat foam 26 against one side of the hips of the baby 5. In particular, the side walls 29 of the seat foam 26 are configured to generally fit the anterior superior iliac spine and greater trochanter of the baby 5 to facilitate the pelvis of the baby 5 to remain stationary. The handles 22 shown in the present embodiment can be replaced by other means / structures to provide the same function to fix the hips of the baby 5.

[0030] The height of the chest support 24 can be adjusted according to the size or height of the child / baby 5 to achieve shoulder fixation. For example, the shoulder contact portion 24b of the chest support 24 engages the shoulders of the baby 5 to fix the position of the upper body in all planes of movement. The portion of the chest support 24 that engages the mirror handle 28 of the chair seat 27 is provided with a plurality of means along its length that engage the lock 23, such that the height of the chest support 24 relative to the chair seat 27 can be releasably adjusted by the lock 23.

[0031] The support system 100 or 200 can also include means (anchoring members) for anchoring itself to the plane. For example, with reference to Figure 15 The support system 200 includes slots for receiving the fixation straps in order to fix them to the top of the operating bed / table.

[0032] It is to be understood that the embodiments and variations illustrated and described herein are only exemplary of the principles of the application and that various modifications can be implemented by those skilled in the art without departing from the spirit and scope of the application.

Claims

1. A device for positioning an infant for a lumbar puncture, comprising: a seat defining a leg support portion, a hip support portion, and a back support portion, wherein the hip support portion and the back support portion accommodate the hips of the infant, and the leg support portion is positioned higher than the hip support portion, thereby bringing the thighs and knees of the infant in close proximity to or in contact with the upper body of the infant to expose the back of the infant for the lumbar puncture.

2. The device of claim 1, further comprising a leg partition for controlling movement of each leg of the infant.

3. The device of claim 1 or 2, further comprising a body holder for securing a curved body position of the infant.

4. The apparatus of claim 3, wherein, the body holder comprises a height-adjustable horizontal bar that presses the thighs of the infant against the seat and causes the upper body of the infant to bend forward over the height-adjustable horizontal bar.

5. The apparatus of claim 3, wherein, the body holder comprises a height-adjustable chest rest for supporting the upper body of the infant.

6. The apparatus of claim 5, wherein, the height-adjustable chest rest is inclined forward.

7. The apparatus of any one of claims 3-5, wherein, the height-adjustable chest rest comprises a shoulder portion to depress the shoulders of the infant toward the seat to secure the body of the infant.

8. The apparatus of claim 7, wherein, the height-adjustable chest rest defines a chin rest portion for receiving the chin of the infant.

9. The device of any one of claims 1 to 7, further comprising a lateral body holder adjustably and operably disposed on a side wall of the seat for securing the hips of the infant.

10. The apparatus of claim 9, wherein, the lateral body holder comprises an actuator that drives a movable jaw into engagement with one side of the hips of the infant.

11. The apparatus of claim 10, wherein, the actuator comprises a screw member and a handle at one end of the screw member, wherein the side wall of the seat defines a port for receiving the screw member to adjust the distance from the side wall to properly engage the movable jaw with one side of the hips of the infant.

12. The device of any one of claims 1 to 11, further comprising an anchoring member for securing the device on a surface of an operating table.

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